Regulation (EC) No 1223/2009 of the European ... - Mattilsynet
Regulation (EC) No 1223/2009 of the European ... - Mattilsynet
Regulation (EC) No 1223/2009 of the European ... - Mattilsynet
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ReferencenumberChemical name/INNName <strong>of</strong> CommonIngredients GlossarySubstance identificationCAS number<strong>EC</strong> numberProduct type, body partsRestrictionsMaximum concentration inready for use preparationO<strong>the</strong>rWording <strong>of</strong> conditions <strong>of</strong>use and warningsL 342/140abcdefghiFor any toothpaste containing0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for children(e.g. ‘for adult useonly’) <strong>the</strong> followinglabelling is obligatory:EN30 Calcium fluoride Calcium fluoride 7789-75-5 232-188-7 Oral products 0,15 % (as F). Whenmixed with o<strong>the</strong>r fluorinecompounds permittedunder this Annex,total F concentrationmust not exceed 0,15 %‘Children <strong>of</strong> 6 years andyounger: Use a pea sizedamount for supervisedbrushing to minimizeswallowing. In case <strong>of</strong>intake <strong>of</strong> fluoride fromo<strong>the</strong>r sources consult adentist or doctor’Contains calcium fluorideFor any toothpaste containing0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for children(e.g. ‘for adult useonly’) <strong>the</strong> followinglabelling is obligatory:‘Children <strong>of</strong> 6 years andyounger: Use a pea sizedamount for supervisedbrushing to minimizeswallowing. In case <strong>of</strong>intake <strong>of</strong> fluoride fromo<strong>the</strong>r sources consult adentist or doctor’Official Journal <strong>of</strong> <strong>the</strong> <strong>European</strong> Union 22.12.<strong>2009</strong>
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